U.S. patent number 8,870,966 [Application Number 13/645,026] was granted by the patent office on 2014-10-28 for intragastric balloon for treating obesity.
This patent grant is currently assigned to Apollo Endosurgery, Inc.. The grantee listed for this patent is Apollo Endosurgery, Inc.. Invention is credited to Mitchell H. Babkes, Tiago Bertolote, Zachary Dominguez, Christopher S. Mudd, Joseph Raven, Justin Schwab.
United States Patent |
8,870,966 |
Schwab , et al. |
October 28, 2014 |
Intragastric balloon for treating obesity
Abstract
A transorally implanted intragastric balloon or treating obesity
and for weight control including a variable size balloon with one
or interconnected regions acting to exert a pressure on the
stomach, to provide a stomach volume occupying effect, and/or to
anchor the balloon within the stomach.
Inventors: |
Schwab; Justin (Santa Barbara,
CA), Dominguez; Zachary (Santa Barbara, CA), Raven;
Joseph (Goleta, CA), Babkes; Mitchell H. (Santa Clarita,
CA), Mudd; Christopher S. (Ventura, CA), Bertolote;
Tiago (Goleta, CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Apollo Endosurgery, Inc. |
Austin |
TX |
US |
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Assignee: |
Apollo Endosurgery, Inc.
(Austin, TX)
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Family
ID: |
47627438 |
Appl.
No.: |
13/645,026 |
Filed: |
October 4, 2012 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20130035711 A1 |
Feb 7, 2013 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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13276182 |
Oct 18, 2011 |
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61394708 |
Oct 19, 2010 |
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61394592 |
Oct 19, 2010 |
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61394145 |
Oct 18, 2010 |
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Current U.S.
Class: |
623/23.64;
606/192 |
Current CPC
Class: |
A61F
5/0036 (20130101); A61F 5/0033 (20130101); A61F
5/003 (20130101) |
Current International
Class: |
A61F
2/04 (20130101) |
Field of
Search: |
;606/139,192,213 ;600/37
;623/23.64 |
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|
Primary Examiner: Nguyen; Victor
Attorney, Agent or Firm: Gordon & Jacobson, PC
Parent Case Text
CROSS REFERENCE
This application is a continuation-in-part of U.S. patent
application Ser. No. 13/276,182, filed Oct. 18, 2011, which claims
priority under 35 U.S.C. .sctn.119 to U.S. Provisional Application
No. 61/394,708, filed Oct. 19, 2010, to U.S. Provisional
Application No. 61/394,592, filed Oct. 19, 2010, and to U.S.
Provisional Application No. 61/394,145, filed Oct. 18, 2010, the
entire contents of which four above cited patent applications are
incorporated herein by reference in their entireties.
Claims
We claim:
1. An intragastric balloon configured to be implanted transorally
into a patient's stomach to treat obesity, the intragastric balloon
comprising: an inflatable hollow body, the body having a body
volume, wherein, in an implanted state, the body includes: an
under-inflated central inflatable member filled partially with a
fluid, and a plurality of outer wings in fluid communication with
the central inflatable member, the outer wings constructed to
transition between a floppy configuration and a stiff configuration
when the under-inflated central inflatable member transitions
between a relaxed configuration and a squeezed configuration when a
compressive force is applied by the stomach to the central
inflatable member, wherein the body is made of a material that
permits the body to be compressed into a substantially linear
transoral delivery configuration, and that will resist degradation
over a period of at least six months within the stomach, wherein
the central inflatable member and the outer wings define a single
internal chamber, such that the fluid can flow freely within the
internal chamber, the body being filled with the fluid having a
fluid volume that is less than the body volume, the body being
constructed to conform to the shape of the stomach.
2. The intragastric balloon of claim 1, wherein the fluid volume is
between about 300 ml and about 700 ml.
3. An intragastric balloon configured to be implanted transorally
into a patient's stomach to treat obesity, the intragastric balloon
comprising: an inflatable hollow body, the body having a volume
between about 300 mls and about 700 mls, which volume is
substantially the same both before and after inflation of the body
with a fluid, the fluid occupying less than the volume of the body,
wherein the body is made of a material that permits the body to be
compressed into a substantially linear transoral delivery
configuration, and that will resist degradation over a period of at
least six months within the stomach, wherein the body has a single
internal chamber with three interconnected regions, such that the
fluid can flow freely between each region, the inflatable body
being under-inflated to conform to the shape of the stomach,
wherein the three regions include, an under-inflated, central
spherical inflatable member, a first elongated outer wing, and a
second elongated outer wing diametrically opposite the first
elongated outer wing such that the first and second outer wings
extend from opposite poles of the central inflatable member.
4. The balloon according to claim 3, wherein the first and second
wings are constructed to transition between a floppy to a stiff
configuration when the central inflatable member is squeezed by the
stomach and fluid from the central member is thereby displaced from
the central member to the first and second wings.
5. The balloon according to claim 4, wherein the first and second
wings are constructed to transition between a floppy to a stiff
configuration when a predetermined compressive force causes the
first and second wings to become stiff.
6. The balloon according to claim 3, wherein the difference in
volume between the volumes of the body and the fluid provides slack
for flow from the central inflatable member to the first and second
wings.
Description
BACKGROUND
The present invention is an intragastric device and uses thereof
for treating obesity, weight loss and/or obesity-related diseases
and, more specifically, to transorally (as by endoscopy) delivered
intragastric devices designed to occupy space within a stomach
and/or stimulate the stomach wall and react to changing conditions
within the stomach.
Over the last 50 years, obesity has been increasing at an alarming
rate and is now recognized by leading government health
authorities, such as the Centers for Disease Control (CDC) and
National Institutes of Health (NIH), as a disease. In the United
States alone, obesity affects more than 60 million individuals and
is considered the second leading cause of preventable death.
Worldwide, approximately 1.6 billion adults are overweight, and it
is estimated that obesity affects at least 400 million adults.
Obesity is caused by a wide range of factors including genetics,
metabolic disorders, physical and psychological issues, lifestyle,
and poor nutrition. Millions of obese and overweight individuals
first turn to diet, fitness and medication to lose weight; however,
these efforts alone are often not enough to keep weight at a level
that is optimal for good health. Surgery is another increasingly
viable alternative for those with a Body Mass Index (BMI) of
greater than 40. In fact, the number of bariatric surgeries in the
United States was estimated to be about 400,000 in 2010.
Examples of surgical methods and devices used to treat obesity
include the LAP-BAND.RTM. (Allergan Medical of Irvine, Calif.)
gastric band and the LAP-BAND AP.RTM. (Allergan). However, surgery
might not be an option for every obese individual; for certain
patients, non-surgical therapies or minimal-surgery options are
more effective or appropriate.
In the early 1980s, physicians began to experiment with the
placement of intragastric balloons to reduce the size of the
stomach reservoir, and consequently its capacity for food. Once
deployed in the stomach, the balloon helps to trigger a sensation
of fullness and a decreased feeling of hunger. These devices are
designed to provide therapy for moderately obese individuals who
need to shed pounds in preparation for surgery, or as part of a
dietary or behavioral modification program. These balloons are
typically cylindrical or pear-shaped, generally range in size from
200-500 ml or more, are made of an elastomer such as silicone,
polyurethane, or latex, and are filled with air, an inert gas,
water, or saline.
One such inflatable intragastric balloon is described in U.S. Pat.
No. 5,084,061 and is commercially available as the BioEnterics
Intragastric Balloon System ("BIB System," sold under the trademark
ORBERA). The BIB System comprises a silicone elastomer intragastric
balloon that is inserted into the stomach and filled with fluid.
Conventionally, the balloons are placed in the stomach in an empty
or deflated state and thereafter filled (fully or partially) with a
suitable fluid. The balloon occupies space in the stomach, thereby
leaving less room available for food and creating a feeling of
satiety for the patient. Placement of the intragastric balloon is
non-surgical, trans-oral, usually requiring no more than 20-30
minutes. The procedure is performed gastroscopically in an
outpatient setting, typically using local anesthesia and sedation.
Placement of such balloons is temporary, and such balloons are
typically removed after about six months. Removing the balloon
requires deflation by puncturing with a gastroscopic instrument,
and either aspirating the contents of the balloon and removing it,
or allowing the fluid to pass into the patient's stomach. Clinical
results with these devices show that for many obese patients, the
intragastric balloons significantly help to control appetite and
accomplish weight loss.
Some attempted solutions for weight loss by placing devices in the
stomach result in unintended consequences. For instance, some
devices tend to cause food and liquid to back up in the stomach,
leading to symptoms of gastroesophageal reflux disease (GERD), a
condition in which the stomach contents (food or liquid) leak
backwards from the stomach into the esophagus. Also, the stomach
acclimates to some gastric implant devices, leading to an expansion
of stomach volume and consequent reduction in the efficacy of the
device.
Therefore, despite many advances in the design of intragastric
obesity treatment implants, there remains a need for improved
devices that can be implanted for longer periods than before or
otherwise address certain drawbacks of intragastric balloons and
other such implants.
SUMMARY
A transorally inserted intragastric device of the present invention
can be used to treat obesity and/or for weight control. The device
can do this by causing a feeling or a sensation of satiety in the
patient on several basis, for example by contacting the inside or a
portion of the inside of the stomach wall of the patient. In
addition, preferably the transoral intragastric device allows for
easy and quick placement and removal. Surgery is usually not
required or is very minimal. In one embodiment, the transoral
intragastric device can be placed in the patient's stomach through
the mouth and the esophagus and then being placed to reside in the
stomach. The transoral intragastric device does not require
suturing or stapling to the esophageal or stomach wall, and can
remain inside the patient's body for a lengthy period of time
(e.g., months or years) before removal.
Each of the disclosed devices is formed of materials that will
resist degradation over a period of at least six months within the
stomach. The implantable devices are configured to be compressed
into a substantially linear transoral delivery configuration and
placed in a patient's stomach transorally without surgery to treat
and prevent obesity by applying a pressure to the patient's
stomach.
In one embodiment, a transoral intragastric device can be used to
treat obesity or to reduce weight by stimulating the stomach walls
of the patient. The intragastric spring device can be a purely
mechanical device comprising a flexible body which in response to
an input force in one direction, may deform and cause a resultant
displacement in an orthogonal direction, thereby exerting a
pressure on the inner stomach walls of the patient.
In another embodiment, a transoral orthogonal intragastric device
can include a variable size balloon. The balloon may be configured
to occupy volume in the patient's stomach, thereby reducing the
amount of space in the patient's stomach.
A still further reactive implantable device disclosed herein has an
inflatable body with an internal volumetric capacity of between
400-700 ml and being made of a material that permits it to be
compressed into a substantially linear transoral delivery
configuration and that will resist degradation over a period of at
least six months within the stomach. The body has a central
inflatable member and at least two outer wings, and a single
internal fluid chamber such that fluid may flow between the central
inflatable member and the outer wings. The inflatable body is under
filled with fluid such that the outer wings are floppy in the
absence of compressive stress on the central inflatable member and
stiff when compressive stress from the stomach acts on the central
inflatable member. The central inflatable member may have a
generally spherical shape along an axis. There are preferably two
outer wings extending in opposite directions from the generally
spherical inflatable member along the axis. In one form, each of
the outer wings includes a narrow shaft portion connected to the
central inflatable member terminating in bulbous heads.
An embodiment of the present invention can be an intragastric
balloon configured to be implanted transorally into a patient's
stomach to treat obesity. Such an intragastric balloon can comprise
an inflatable hollow body, the body having a volume which is
substantially the same both before and after inflation of the body
with a fluid. The body can be made of a material that permits the
body to be compressed into a substantially linear transoral
delivery configuration, and that will resist degradation over a
period of at least six months within the stomach. Additionally, the
body can have a single internal chamber with one or more
interconnected regions, such that the fluid can flow between each
region, the inflatable body being under filled with the fluid such
that the once inflated the body is not rigid, thereby having the
capability to confirm to the shape of a the stomach. For this
intragastric balloon the volume can be between about 300 ml and
about 700 ml.
An embodiment of the intragastric balloon disclosed in the
paragraph can have three regions, a proximal region for inducing
satiety by exerting a pressure on the stomach, a larger central
region for inducing satiety by providing a stomach volume occupying
effect, and a smaller distal region for anchoring the balloon
within the stomach. The intragastric balloon can also have an
increased thickness of the distal region shapes for preventing
migration of the balloon out of the distal stomach. Additionally,
the intragastric can also have in the central region a
circumferential ring to for help prevent collapse of the balloon.
Furthermore, in the proximal region of the balloon there can be a
spine for maintaining the shape of the balloon.
An detailed embodiment of the present invention can be an
intragastric balloon configured to be implanted transorally into a
patient's stomach to treat obesity, the intragastric balloon
comprising: an inflatable hollow body, the body having a volume
between about 300 ml and about 700 mls, which volume is
substantially the same both before and after inflation of the body
with a fluid, wherein the body is made of a material that permits
the body to be compressed into a substantially linear transoral
delivery configuration, and that will resist degradation over a
period of at least six months within the stomach, wherein the body
has a single internal chamber with one or more interconnected
regions, such that the fluid can flow between each region, the
inflatable body being under filled with the fluid such that the
once inflated the body is not rigid, thereby having the capability
to confirm to the shape of a the stomach, wherein the body has
three regions, a proximal region for inducing satiety by exerting a
pressure on the stomach, a larger central region for inducing
satiety by providing a stomach volume occupying effect, and a
smaller distal region for anchoring the balloon within the stomach,
wherein the distal region further comprises an increased thickness
for preventing migration of the balloon out of the distal stomach,
the central region further comprises a circumferential ring for
helping preventing collapse of the inflated or deflated balloon,
and the proximal region further comprises a spine for helping to
maintain the shape of the balloon.
DRAWINGS
The following detailed descriptions are given by way of example,
but not intended to limit the scope of the disclosure solely to the
specific embodiments described herein, may best be understood in
conjunction with the accompanying drawings in which:
FIG. 1 illustrates a reactive intragastric implant comprising an
under filled inflatable member having outer wings that transition
between floppy to stiff configurations.
FIGS. 2A and 2B show the intragastric implant of FIG. 1 implanted
in the stomach in both relaxed and squeezed states, showing the
transition of the outer wings between floppy and stiff
configurations.
FIG. 3A is diagram illustrating on the left hand side of FIG. 3A an
unfilled known intragastric balloon. The right pointing arrow in
FIG. 3A represents filling 700 ml of saline into the unfilled
intragastric balloon, resulting as shown on the right hand side of
FIG. 3A in a balloon shell that is stretched and a balloon that is
rigid. The upwards pointing arrow in FIG. 3A represents the high
pressure that is exerted by the 700 ml filled balloon onto the
inside wall of a patient's stomach by the so filled intragastric
balloon. Thus there is a positive differential pressure in the
balloon relative to outside of the balloon (i.e. differential
pressure>0).
FIG. 3B is a corresponding diagram illustrating on the left hand
side of FIG. 3B an unfilled compliant intragastric balloon. The
right pointing arrow in FIG. 3B represents filling 700 ml of saline
into the unfilled intragastric balloon, resulting as shown on the
right hand side of FIG. 3BA in a balloon shell that is under
minimal strain and a balloon that is compliant. The downwards
pointing arrow in FIG. 3B represents the lower pressure that is
exerted by the 700 ml filled compliant balloon, by a differing or
amorphous balloon shell shape, onto the inside wall of a patient's
stomach by the so filled compliant intragastric balloon. Thus,
there exists a zero or negligible differential pressure in the
balloon relative to the outside of the balloon (i.e. differential
pressure is zero or almost zero).
FIG. 4 is an illustrative, perspective view of a saline containing
compliant balloon implanted within a patient's stomach, with the
proximal (near) stomach wall removed to show the balloon
therein.
FIG. 5 is a perspective view of the mandrel (the work piece or
mold) over which a liquid polymer (i.e. silicone) dispersion is
placed (as by a serial dipping procedure) and then heat cured so as
to create the compliant balloon of FIG. 4.
FIGS. 6A to 6G are diagramatic illustrations of compliant balloon
geometries, alternative to those of FIGS. 4 and 5, within the scope
of the present invention.
FIG. 7 is an illustrative, perspective view of a further embodiment
(kidney shaped), saline containing compliant balloon implanted
within a patient's stomach, with the proximal (near) stomach wall
removed to show the balloon therein.
FIG. 8A to 8C are diagramatic illustrations of three further
embodiments of compliant balloons within the scope of the present
invention.
FIG. 9A is a diagram of a mandrel useful for making a further
embodiment of the present intragastric balloon.
FIG. 9B is a diagram of another mandrel useful for making a further
embodiment of the present intragastric balloon.
FIG. 9C is a diagram of another mandrel useful for making a further
embodiment of the present intragastric balloon.
FIG. 9D is a diagram of another mandrel useful for making a further
embodiment of the present intragastric balloon.
FIG. 10 is a diagram of an inflated intragastric balloon made using
the FIG. 9A mandrel.
FIG. 11 is a perspective photograph of an intragastric balloon of
the present invention enclosed by a novel delivery sheath.
DESCRIPTION
The present invention is based on the discovery that an under
filled intragastric balloon can be made to have, once so under
filed ("inflated"), a geometry (shape upon inflation) which is
flexible or "amorphous", as opposed to having a rigid shape. Unlike
the present invention, a rigid upon inflation intragastric balloon
does not conform to the shape of the lumen of the stomach into
which the balloon is implanted. In one embodiment, an intragastric
device described herein can be placed inside the patient,
transorally and without invasive surgery, without associated
patient risks of invasive surgery and without substantial patient
discomfort. Patient recovery time can be minimal as no extensive
tissue healing is required. The life span of the intragastric
devices can be material dependent and is intended for long term
survivability within an acidic stomach environment for a least
about six months, although it can be one year or longer.
FIG. 1 illustrates a reactive intragastric implant 100 comprising
an under filled central inflatable member 102 having outer wings
104 that transition between floppy to stiff configurations. The
entire implant 100 defines a single fluid chamber therein. In the
illustrated embodiment, the inflatable member 102 is substantially
spherical, while the outer wings 104 resemble stems with a narrow
proximal shaft 106 terminating in a bulbous head 108. Also, a pair
of the outer wings 104 extend from opposite poles of the spherical
inflatable member 102, which is believed to facilitate alignment of
the implant 100 within the stomach, though more than two such wings
distributed more evenly around the inflatable member could be
provided.
FIG. 2A shows the intragastric implant 100 implanted in the stomach
in a relaxed state, while FIG. 2B shows the implant 100 in a
squeezed state, illustrating the transition of the outer wings 104
between floppy (FIG. 2A) and stiff (FIG. 2B) configurations. The
shape of the central inflatable member 102 in FIG. 2B is a
representation of the shape as if squeezed by the surrounding
stomach walls, however the illustrated stomach is shown in its
relaxed configuration. Transition between the relaxed and squeezed
state of the implant 100 occurs when the stomach walls squeeze the
central inflatable member 102, thus pressurizing the outer wings
104. In other words, fluid is driven from the central member 102
and into the outer wings 104.
Initially, the entire implant 100 is under filled with a fluid such
as saline or air to a degree that the wings 104 are floppy, and a
predetermined compressive force causes them to become stiff. For
example, the fully filled volume of the intragastric implant 100
may be between 400-700 ml, though the implant is filled with less
than that, thus providing slack for flow into the wings 104.
Additionally, it should be noted that under filling the implant 100
results in lower stresses within the shell wall, which may improve
the degradation properties of the material within the stomach's
harsh environment.
It should also be stated that any of the embodiments described
herein may utilize materials that improve the efficacy of the
implant. For example, a number of elastomeric materials may be used
including, but not limited to, rubbers, fluorosilicones,
fluoroelastomers, thermoplastic elastomers, or any combinations
thereof. The materials are desirably selected so as to increase the
durability of the implant and facilitate implantation of at least
six months, and preferably more than 1 year.
Material selection may also improve the safety of the implant. Some
of the materials suggested herein, for example, may allow for a
thinner wall thickness and have a lower coefficient of friction
than the implant.
The implantable devices described herein will be subjected to
clinical testing in humans. The devices are intended to treat
obesity, which is variously defined by different medical
authorities. In general, the terms "overweight" and "obese" are
labels for ranges of weight that are greater than what is generally
considered healthy for a given height. The terms also identify
ranges of weight that have been shown to increase the likelihood of
certain diseases and other health problems.
An embodiment of the present invention is an intragastric balloon
with a tolerance greater than that of the intragastric balloon
shown in FIGS. 1, 2 and 3A. Greater tolerance can be achieved by
having a larger allowable amount of variation of a specified
quantity, such as in the volume and/or in the shape, of the
intragastric balloon of the present invention. Such a greater
tolerance intragastric balloon can also be referred to as a more
compliant intragastric balloon. A more compliant intragastric
balloon can provide many advantages for the treatment of obesity.
Thus, known intragastric balloons require the device be filled with
from 400 ml to 900 ml of a fluid (typically saline or air)
resulting once so filled in an intragastric balloon with a rigid,
spherical implant geometry (as in FIG. 3A). Such a geometry can be
responsible for one or more of the known post-op (that is after
transoral placement [implantation] of the intragastric device into
the lumen of the stomach of a patient) adverse effects which can
include nausea, intolerance (demanded removal of the device),
abdominal pain, vomiting, reflux, and gastric perforation. Thus,
when fluid filled, known intragastric devices undergo significant
strain, and provide a relatively rigid fluid filled (inflated)
balloon.
An intragastric balloon with increased tolerance (compliance)
according to the present invention can provide superior gastric
volume occupying benefits as compared to a known intragastric
balloon, such as the ORBERA.TM. bariatric intragastric balloon,
(available from Allergan UK, Marlow, England), as well as reduced
adverse events in the period following device implantation.
ORBERA.TM. is a saline filled silicone balloon that is placed in
the stomach of a patient, filled with 400-700 ml of saline, and
then left in the stomach for up to six months to provide a feeling
of fullness, reduced appetite and weight loss.
An embodiment of the present invention is an intragastric balloon
with increased tolerance (a "compliant balloon" therefore) with a
shell (a volume holding reservoir), and a valve for inflation. Both
parts can be made of silicone or other suitable material and can be
implanted and explanted transorally, through the esophagus, and
into/out of the stomach during a minimally invasive
gastroendoscopic procedure.
Importantly, the compliant balloon of the present invention upon
inflation has an amorphous or variable (non-rigid) geometry due to
the relationship between the volume of the shell and volume of
fluid that is placed into (used to fill) the shell. Additionally,
the compliant balloon has a relatively larger and more relaxed
silicone shell (as compared to a device such as ORBERA.TM.) thereby
making the shell strain and rigidity comparably less than known
intragastric balloons (as compared to ORBERA.TM.) which contain the
same or a similar fill volume. The increased compliance, with the
same volume occupation, provides an improved balloon shape, and the
ability of a balloon within the scope of the present invention to
readily conform to and/or to contour to individual patient stomach
anatomy (that is to the patient's particular internal stomach lumen
volume and/or configuration) thereby reducing adverse events upon
implantation, while still providing a treatment of obesity. FIG. 3
illustrates a principle or feature of an embodiment of the present
invention to show an important difference between a known or
standard intragastric balloon 200 (FIG. 3A) and an embodiment of
the present compliant intragastric balloon 300 (FIG. 3B). In a
standard balloon configuration 200, a smaller initial shell (the
left hand side of FIG. 3A) is inflated (eg with a fluid such as
saline) which stretches the balloon shell, thereby increasing
internal pressure, and creates a rigid sphere, as shown by the
right hand side of FIG. 3A. Contrarily, a compliant balloon 300 has
a larger initial shell volume (the left hand side of FIG. 3B) and
can be inflated to a similar volume, but does not place the shell
under major stretch which decreases internal pressure (as compared
to the inflated FIG. 3A balloon) and produces an inflated
intragastric balloon with an amorphous or irregular shape, as shown
by the right hand side of FIG. 3B.
Another embodiment 400 of the present invention compliant balloon
(roughly kidney shaped) is shown by FIG. 4, inflated within a
stomach. This design 400 incorporates three balloon regions: a
proximal medium sized portion 410, a large central portion 420, and
a smaller distal portion 430. The medium proximal portion 410
provides a balloon shell surface area which contacts and exerts a
pressure on the proximal stomach to thereby induce satiety. The
larger central portion 420 functions as a stomach space filling
region which sterically reduces appetite by preventing ingested
food from occupying the same stomach volume. Smallest of the three
compliant balloon regions, portion 430 conforms to the more
muscular, narrow antrum region of the stomach helping to maintain
("anchor") the balloon within the stoma.
Thus, the embodiment 400 shown in FIG. 4 that has a larger central
sphere 420, and is overall kidney shaped. The volume compliance
aspect of embodiment 400, as well as it's anatomically more natural
geometry provides a device that better conforms to stomach anatomy
which providing maximum stomach volume occupation.
FIG. 5 shows a dipping mandrel 500 that can used as a mold to
create the balloon 400, using known silicone shell production
methods. As shown by FIG. 5, the mandrel 500 has radii (shown by
the arrows in FIG. 5) connecting the spheres. The radii can be
reduced in size (shorter) to thereby making the portions 410, 420
and 430 more defined (more spherical). Alternately, the radii can
be increased (longer) in size to thereby making the portions 410,
420 and 430 less defined (less spherical). Potential benefits of
better defined (reduced radii) balloon portions of the implant can
include ease of implantation and the filling procedure, or
compacting for delivery through the esophagus. Additionally,
benefits for less defined (longer radii) balloon portions could
include more stomach surface area contact, and fewer stress
concentrations on the shell.
An embodiment of the compliant balloon can be modified in any
number of ways, while maintaining the core benefits of a compliant
balloon, for example for increased conformance of anatomy, reduced
shell stresses, reduced patient adverse events, and equivalent
gastric volume occupation and FIG. 6 illustrates some, but not all,
potential alternatives. Thus FIG. 6 shows seven (A to G)
alternative compliant balloon geometries with one or more radii
altered. Note the dotted transitions between the individual
sections of each design, which represents the variable connecting
taper/curve that could be applied between each balloon portion.
"Proximal" and "Distal" in FIG. 6 represent how the device would be
placed in a patient's anatomy (proximal is closer to head).
FIG. 7 illustrates a kidney shaped embodiment 600 shown within a
human stomach. Embodiment 600 has a single balloon shape (only one
unity shaped balloon region). Thereby as shown in FIG. 7 permitting
embodiment 600 to have close conformance to internal stomach
anatomy, without requiring the stomach to reshape (as would be
required with a large spherical geometry intragastric balloon).
Embodiment 600 is also graphically illustrated in FIGS. 6D and 6F
with a tangential shell taper.
Due to the increased compliance of the device 600, additional
features can be applied to the design to prevent, or induce certain
physiological and device related occurrences, for example because
of the conformity and amorphous shell of device 600, features may
be added to prevent premature passing of the device through the
pylorus, as shown by FIG. 8. Thus, FIG. 8 shows features that can
be added to a compliant balloon within the scope of the present
invention to help maintain certain shapes, or prevent unintentional
migration into the pylorus: A in FIG. 8 shows increased thickness
on the distal balloon segment, which would increase rigidity along
the section of device that is most likely to enter the pylorus; B
in FIG. 8 shows a circumferential, or series, of rings which would
prevent collapse and eventual migration of the device into the
duodenum, and; C in FIG. 8 is one of several spines which can help
maintain desired balloon shape.
Removal Features
It is known to use for the manufacture of an intragastric balloon a
spherically shaped mandrel that is simply a to scale (i.e. scaled)
version of the desired final intragastric balloon spherical shape,
once inflated. Thus, a spherical intragastric balloon such as
Orbera can be made using a similarly spherical mandrel. It has been
thought that anatomical (i.e. the shape of the stomach lumen) and
endoscopic insertion (i.e. the physical parameters of the
esophagus, and ability to insert with patient safety and comfort
maintained) requirements dictate use of a spherical intragastric
balloon and hence use of a spherical mandrel mandrel.
Significantly, we have invented mandrels with non-spherical shapes
so that the resulting inflated intragastric balloons have
concomitant non-spherical shapes. One benefit of using a
non-spherical mandrel is that the resulting intragastric balloon
made thereon can retain the shape of the non-spherical mandrel once
the intragastric balloon has been deflated, unlike the situation
with an intragastric balloon made on a spherical mandrel. An
additional benefit of using a non-spherical mandrel is that the
resulting non-spherical intragastric balloon can facilitate easy
grasping for improved removal of the non-spherical intragastric
balloon from the stomach of the patient. Furthermore, use of a
non-spherical mandrel also can facilitate easy grasping and
improved removal of completed non-spherical intragastric balloon
from the mandrel because a spherical mandrel can be difficult to
grasp due to the lack of grasping features on the manufactured
shell of the spherical intragastric balloon. An embodiment of our
non-spherical intragastric balloon shell is much easier to grasp
for removal from the mandrel because the shell has folds or other
features in the shell that assist grasping.
FIG. 9A to 9D show several non-spherical mandrel embodiments that
incorporate features which aid removal of the shell from the
mandrel. The geometry of the FIG. 9A to 9D mandrels is such that
there exist one or more features of the resulting shell formed on
the mandrel which make manipulation or grasping of the balloon much
easier, as compared to a spherical intragastric balloon shell made
on a spherical mandrel. Thus FIGS. 9A to 9D illustrate mandrel
features that create a shell with a fold or fold-like geometry
which result in the shell being more readily grasped and removed
from the mandrel. Specifically, FIG. 9A is a diagram of a mandrel
700 with a cavity 710 useful for making an embodiment of the
present intragastric balloon. FIG. 9B is a diagram of another
mandrel 800 useful for making another embodiment of the present
intragastric balloon. Mandrel 800 has one or more circular or
semi-circular latitudinal ridges 810 to assist grasping and removal
of the intragastric balloon formed thereon. FIG. 9C is a diagram of
another mandrel 900 useful for making another further embodiment of
the present intragastric balloon. Mandrel 900 has one or more
circular or semi-circular longitudinal ridges 910 to assist
grasping and removal of the intragastric balloon formed thereon.
FIG. 9D is a diagram of another mandrel 1000 useful for making
another embodiment of the present intragastric balloon. Mandrel
1000 has one or spaced pits 1010 to assist grasping and removal of
the intragastric balloon formed thereon.
FIG. 10 is a diagram showing an embodiment 1100 of an inflated
intragastric balloon made using mandrel 700.
Barium Integration:
Visualization of intragastric balloons in a patient is often done
endoscopically. While this offers the greatest visibility, it is
also fairly invasive. On the other hand, fluoroscopy or radiographs
are far less invasive, but typically provide poor visualization of
the lumen of the stomach making eg the intra-stomach lumen location
and amount of inflation of the intragastric balloon difficult or
impossible to determine. For example using x rays many intragastric
balloons being made of thermoplastics and thermoset plastic are
difficult to differentiate from surrounding tissue.
To address and resolve these deficiencies of existing visualization
methods of an inserted (in the stomach) intragastric balloon
visualization we developed intragastric balloons in which a
radiopaque substance is incorporated into the shell of the
intragastric balloon thereby dramatically improving intra-luminal
visualization. Thus, by optimizing the radiopacity of the entire
intragastric balloon visualization with minimally invasive x-ray
technologies is greatly improved. A suitable radiopaque substance
(such as barium sulfate) can be incorporated into the intragastric
balloon homogeneously, or it may be incorporated in different
amounts in various layers of the shell of the intragastric device.
In a particular embodiment because addition of barium sulfate can
reduce the GI/stomach acid resistance of the intragastric device
shell material, the barium sulfate is incorporated into the inner
layer(s) of the intragastric device shell, while leaving the outer
layers of the intragastric device shell as more resistant.
Methods of Delivery
The Orbera intragastric device has a silicone sheath. As the Orbera
balloon is inflated, the sheath stretches and tears in areas that
are pre-cut. Full inflation of the balloon ensures complete
deployment of the Orbera balloon and valve from its sheath. With
the present compliant intragastric balloon, this same sheath is
unsuitable, because the present intragastric balloon is
underinflated (relative to mandrel size) so that present
intragastric balloon never exerts enough force on the sheath to
allow for full deployment. Therefore an alternative intragastric
device delivery (insertion) method was developed as set forth
below.
As shown by FIG. 11 one such method developed involves wrapping the
intragastric balloon in a sheath 1200 with a suture that is tied in
a series of slip knots 1210. A slip string 1220 runs along the
length of the fill tube and is long enough to pull from outside the
body (after the intragastric balloon is placed in the stomach).
Pulling on the string 1220 unties all of the knots 1210 and frees
the (uninflated) intragastric balloon in the stomach. The string
1220 is then retrieved from the stomach and the intragastric
balloon is filled as usual.
In an alternative embodiment, one can use vision a piece of
sheeting that wraps the intragastric balloon. This sheeting can be
held closed with a string or some other component that can be
activated upon command. Activation of this component (string for
example) would loosen the wrap and free the device. The string and
wrap could then be retrieved from the stomach.
To summarize, the compliant balloon provides: a soft, compliant
implant that is capable of conforming to patient's anatomy while
providing gastric volume occupation (i.e. resulting in the patient
experience a feeling of fullness); greater patient tolerance of the
implant, resulting in reduced recorded post-operative adverse
events; low level of strain on the compliant balloons thereby
increasing device longevity in the stomach and increased implant
durability and resistance to degradation in the gastric
environment; reduced patient ulcers and lesions that can be
associated with known rigid volume occupying intragastric balloon
implants; a low pressure device, as opposed to known intragastric
balloons that have increased internal pressure proportional to
their fill volume.
EXAMPLE
Example 1
Implantation of a Compliant Balloon
The compliant balloon can be made of a silicone material such as
3206 silicone. Any fill valve can be made from 4850 silicone with
6% BaSo.sub.4. Tubular structures or other flexible conduits can be
made from silicone rubber as defined by the Food and Drug
Administration (FDA) in the Code of Federal Regulations (CFR) Title
21 Section 177.2600. The compliant balloon is intended to occupy a
gastric space while also applying intermittent pressure to various
and changing areas of the stomach; the device can stimulate
feelings of satiety, thereby functioning as a treatment for
obesity. The device is implanted transorally via endoscope into the
corpus of the stomach using endoscopy. Nasal/Respiratory
administration of oxygen and isoflurane is used to maintain
anesthesia as necessary.
The compliant balloon within the scope of the present invention can
be used for the treatment of obesity as follows. A 45 male patient
with a body mass index of 42 who has failed a regime of dieting and
exercise, is recalcitrant to oral medication, declines sleeve
gastrectomy, or other restrictive GI surgery, has comorbidies
including diabetes, high blood pressure and reduced life expectancy
sign an informed consent for implantation of the compliant balloon.
After an overnight fast, under midazolam conscious sedation (max, 5
mg), endoscopy is performed to rule out any GI abnormalities that
would preclude the procedure on the patient. A balloon 400 or 600
is then inserted into the gastric fundus, and 300 ml saline
solution is used for balloon inflation, under direct endoscopic
vision. The patient remains for 2 hours in the recovery room, to
verify full recovery from sedation, before discharge. Weight loss
commence almost immediately and the patient reports no nausea,
intolerance, abdominal pain, vomiting, or reflux, and no gastric
perforation occurs.
An alternate more detailed implant procedure is as follows:
a) Perform preliminary endoscopy on the patient to examine the GI
tract and determine if there are any anatomical anomalies which may
affect the procedure and/or outcome of the study.
b) Insert and introducer into the over-tube.
c) Insert a gastroscope through the introducer inlet until the
flexible portion of the gastroscope is fully exited the distal end
of the introducer.
d) Leading under endoscopic vision, gently navigate the
gastroscope, followed by the introducer/over-tube, into the
stomach.
e) Remove gastroscope and introducer while keeping the over-tube in
place. Optionally place the insufflation cap on the over-tubes
inlet, insert the gastroscope, and navigate back to the stomach
cavity. Optionally, insufflate the stomach with air/inert gas to
provide greater endoscopic visual working volume.
f) Collapse the gastric implant and insert the lubricated implant
into the over-tube, with inflation catheter following if
required.
g) Under endoscopic vision, push the gastric implant down the
over-tube with gastroscope until visual confirmation of deployment
of the device into the stomach can be determined.
h) Remove the guide-wire from the inflation catheter is used.
i) To inflate using 50-60 cc increments of sterile saline, up to
about 300 ml fill volume.
j) Remove the inflation catheter via over-tube.
k) Inspect the gastric implant under endoscopic vision for valve
leakage, and any other potential anomalies.
l) Remove the gastroscope from over-tube.
m) Remove the over-tube from the patient.
Unless otherwise indicated, all numbers expressing quantities of
ingredients, properties such as molecular weight, reaction
conditions, and so forth used in the specification and claims are
to be understood as being modified in all instances by the term
"about." Accordingly, unless indicated to the contrary, the
numerical parameters set forth in the specification and attached
claims are approximations that may vary depending upon the desired
properties sought to be obtained. At the very least, and not as an
attempt to limit the application of the doctrine of equivalents to
the scope of the claims, each numerical parameter should at least
be construed in light of the number of reported significant digits
and by applying ordinary rounding techniques.
All publications cited herein are incorporated herein by reference.
Embodiments of the invention disclosed herein are illustrative of
the present invention. Other modifications that may be employed are
within the scope of the invention. Thus, by way of example, but not
of limitation, alternative configurations of the present invention
may be utilized in accordance with the teachings herein.
Accordingly, the present invention is not limited to that precisely
as shown and described.
* * * * *